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https://www.readbyqxmd.com/read/28543183/a-novel-k-competitive-acid-blocker-yh4808-sustains-inhibition-of-gastric-acid-secretion-with-a-faster-onset-than-esomeprazole-randomised-clinical-study-in-healthy-volunteers
#1
S Yi, H Lee, S B Jang, H M Byun, S H Yoon, J-Y Cho, I-J Jang, K-S Yu
BACKGROUND: YH4808, a K(+) -competitive acid blocker, is under clinical development for the treatment of acid-related disorders, such as gastroesophageal reflux disease. AIMS: We aimed to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of YH4808, compared to placebo and esomeprazole. METHODS: This double-blind, randomised, placebo- and active comparator (esomeprazole)-controlled study was conducted with 123 healthy male volunteers...
May 21, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28542866/pharmacokinetic-pharmacodynamic-evaluation-of-marbofloxacin-as-a-single-injection-for-pasteurellaceae-respiratory-infections-in-cattle-using-population-pharmacokinetics-and-monte-carlo-simulations
#2
A Paulin, M Schneider, F Dron, F Woehrle
Population pharmacokinetic of marbofloxacin was investigated with 52 plasma concentration-time profiles obtained after intramuscular administration of Forcyl® in cattle. Animal's status, pre-ruminant, ruminant, or dairy cow, was retained as a relevant covariate for clearance. Monte Carlo simulations were performed using a stratification by status, and 1000 virtual disposition curves were generated in each bovine subpopulation for the recommended dosage regimen of 10 mg/kg as a single injection. The probability of target attainment (PTA) of pharmacokinetic/pharmacodynamic (PK/PD) ratios associated with clinical efficacy and prevention of resistance was determined in each simulated subpopulation...
May 19, 2017: Journal of Veterinary Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28542307/the-mouse-char10-locus-regulates-severity-of-pyruvate-kinase-deficiency-and-susceptibility-to-malaria
#3
Aurélie Laroque, Gundula Min-Oo, Mifong Tam, Prem Ponka, Mary M Stevenson, Philippe Gros
Pyruvate kinase (PKLR) deficiency protects mice and humans against blood-stage malaria. Although mouse strain AcB62 carries a malaria-protective PklrI90N genetic mutation, it is phenotypically susceptible to blood stage malaria induced by infection with Plasmodium chabaudi AS, suggesting a genetic modifier of the PklrI90N protective effect. Linkage analysis in a F2 cross between AcB62 (PklrI90N) and another PK deficient strain CBA/Pk (PklrG338D) maps this modifier (designated Char10) to chromosome 9 (LOD = 10...
2017: PloS One
https://www.readbyqxmd.com/read/28542036/a-survey-of-renal-impairment-pharmacokinetic-studies-for-new-oncology-drug-approvals-in-the-usa-from-2010-to-early-2015-a-focus-on-development-strategies-and-future-directions
#4
Jim J Xiao, Jiyun S Chen, Bert L Lum, Richard A Graham
The US Food and Drug Administration (FDA) issued a guidance document in 2010 on pharmacokinetic (PK) studies in renal impairment (RI) on the basis of observations that substances such as uremic toxins might result in altered drug metabolism and excretion. No specific recommendations for oncology drugs were included. We surveyed the publicly available FDA review documents of 29 small molecule oncology drugs approved between 2010 and the first quarter of 2015. The objectives were as follows: (i) summarize the impact of RI on PK at the time of the initial new drug application; (ii) identify limitations of the guidance; and (iii) outline an integrated approach to study the impact of RI on these drugs...
May 24, 2017: Anti-cancer Drugs
https://www.readbyqxmd.com/read/28539464/phase-ib-pilot-study-to-evaluate-reparixin-in-combination-with-weekly-paclitaxel-in-patients-with-her-2-negative-metastatic-breast-cancer-mbc
#5
Anne F Schott, Lori Goldstein, Massimo Cristofanilli, Pier Adelchi Ruffini, Susan McCanna, James M Reuben, Raymond Perez, Giraldo Kato, Max S Wicha
CXCR1 is recognized as an actionable receptor selectively expressed by breast cancer stem cells (BCSC). Reparixin is an investigational allosteric inhibitor of chemokine receptors 1 and 2 (CXCR1/2), and demonstrates activity against BCSC in human breast cancer xenografts. This Phase Ib clinical trial examined dose, safety, and pharmacokinetics of paclitaxel plus reparixin therapy, and explored effects of reparixin on BCSCs in metastatic breast cancer (MBC) patients (Trial registration ID: NCT02001974). <p>Experimental Design: Eligible patients had MBC and were candidates for paclitaxel therapy...
May 24, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28535079/the-tomato-kinase-pti1-contributes-to-production-of-reactive-oxygen-species-in-response-to-two-flagellin-derived-peptides-and-promotes-resistance-to-pseudomonas-syringae-infection
#6
Simon Schwizer, Christine M Kraus, Diane M Dunham, Yi Zheng, Noe Fernandez-Pozo, Marina A Pombo, Zhangjun Fei, Suma Chakravarthy, Gregory Martin
The Pti1 kinase was identified from a reverse genetic screen as contributing to pattern-triggered immunity (PTI) against Pseudomonas syringae pv. tomato (Pst). This was unexpected because Pti1 was originally identified as an interactor of the Pto kinase and was implicated in effector-triggered immunity. The tomato genome has two Pti1 genes, referred to as Pti1a and Pti1b. A hairpin-Pti1 (hpPti1) construct was developed and used to generate two independent stable transgenic tomato lines, which had reduced transcript abundance of both genes...
May 23, 2017: Molecular Plant-microbe Interactions: MPMI
https://www.readbyqxmd.com/read/28528287/population-pharmacokinetics-of-oxcarbazepine-and-its-metabolite-10-hydroxycarbazepine-in-healthy-subjects
#7
Natalicia de Jesus Antunes, Sven C van Dijkman, Vera Lucia Lanchote, Lauro Wichert-Ana, Eduardo Barbosa Coelho, Veriano Alexandre Junior, Osvaldo Massaiti Takayanagui, Eduardo Tozatto, Johan G C van Hasselt, Oscar Della Pasqua
Oxcarbazepine is indicated for the treatment of partial or generalized tonic-clonic seizures. The majority of the oxcarbazepine is converted into its active metabolite, 10-hydroxycarbazepine (MHD), which can exist as R-(-)- and S-(+)-MHD enantiomers. Here we describe the influence of the P-glycoprotein (P-gp) inhibitor verapamil, on the disposition of oxcarbazepine and MHD enantiomers, both of which are P-gp substrates. Healthy subjects (n=12) were randomized to oxcarbazepine or oxcarbazepine combined with verapamil at doses of 300mg b...
May 17, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28526988/identification-of-candidate-genes-for-paratuberculosis-resistance-in-the-native-italian-garfagnina-goat-breed
#8
Francesca Cecchi, Claudia Russo, Daniela Iamartino, Alessia Galiero, Barbara Turchi, Filippo Fratini, Sara Degl'Innocenti, Raffaele Mazza, Stefano Biffani, Giovanna Preziuso, Carlo Cantile
Paratuberculosis disease is a chronic bacterial disease infection of ruminants of global relevance, caused by MAP (Mycobacterium avium subsp. paratuberculosis). The present study was conducted on the Garfagnina goat breed that is an Italian native goat population registered on the Tuscan regional repertory of genetic resources at risk of extinction. Forty-eight adult goats (27 serologically positive to MAP-positive and 21 serologically negative to MAP-negative) belonging to a single flock that had experienced annual mortalities due to MAP infection were identified and genotyped with the Illumina GoatSNP60 BeadChip...
May 19, 2017: Tropical Animal Health and Production
https://www.readbyqxmd.com/read/28526601/model-based-precision-dosing-of-sirolimus-in-pediatric-patients-with-vascular-anomalies
#9
Tomoyuki Mizuno, Chie Emoto, Tsuyoshi Fukuda, Adrienne M Hammill, Denise M Adams, Alexander A Vinks
Sirolimus is the first drug to show efficacy in the treatment of patients with complicated vascular anomalies. The current study expands on the evolution of a PK model-based strategy for the precision dosing of sirolimus as part of prospective concentration controlled clinical trials in pediatric patients with vascular anomalies. Twelve month follow up data collected from 52 pediatric patients participating in the Phase 2 clinical trial were analyzed. Target attainment across the age range of 3weeks to 18years after 2-3months of therapy was 94% (49 out of 52 patients)...
May 16, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28526501/hypoxia-modulates-cell-migration-and-proliferation-in-placenta-derived-mesenchymal-stem-cells
#10
Li Li, Prashant Kumar Jaiswal, Georges Makhoul, Rishi Jurakhan, Kaviyanka Selvasandran, Khalid Ridwan, Renzo Cecere
OBJECTIVES: For more than a decade, stem cells isolated from different tissues have been evaluated in cell therapy. Among them, the human bone marrow-derived mesenchymal stem cells (hBM-MSCs) were investigated extensively in the treatment of myocardial infarction. Recently, the human placenta-derived mesenchymal stem cells (hPD-MSCs), which are readily available from a biological waste, appear to be a viable alternative to hBM-MSCs. METHODS: C-X-C chemokine receptor type 4 (CXCR4) gene expression and localization were detected and validated in hPD-MSCs and hBM-MSCs via polymerase chain reaction and immunofluorescence...
April 13, 2017: Journal of Thoracic and Cardiovascular Surgery
https://www.readbyqxmd.com/read/28526373/coffee-consumption-in-aged-mice-increases-energy-production-and-decreases-hepatic-mtor-levels
#11
Keita Takahashi, Shuichi Yanai, Kentaro Shimokado, Akihito Ishigami
OBJECTIVE: Coffee, one of the world's most consumed beverages, has many benefits. Some studies have reported the effects of coffee on aging. The aim of this study was to investigate the locomotor activity, energy metabolism, and lipid metabolism of aged (20-mo-old) mice given coffee. METHODS: Aged C57 BL/6 NCr mice were divided into three groups: controls that were not given coffee (n = 9), a group that received 0.1% caffeinated coffee (n = 9), and a group that received 0...
June 2017: Nutrition
https://www.readbyqxmd.com/read/28525967/candidate-gene-based-association-mapping-in-fusarium-culmorum-for-field-quantitative-pathogenicity-and-mycotoxin-production-in-wheat
#12
Valheria Castiblanco, Jose J Marulanda, Tobias Würschum, Thomas Miedaner
BACKGROUND: Quantitative traits are common in nature, but quantitative pathogenicity has received only little attention in phytopathology. In this study, we used 100 Fusarium culmorum isolates collected from natural field environments to assess their variation for two quantitative traits, aggressiveness and deoxynivalenol (DON) production on wheat plants grown in four different field environments (location-year combinations). Seventeen Fusarium graminearum pathogenicity candidate genes were assessed for their effect on the aggressiveness and DON production of F...
May 19, 2017: BMC Genetics
https://www.readbyqxmd.com/read/28523596/pharmacokinetics-and-safety-of-vismodegib-in-patients-with-advanced-solid-malignancies-and-hepatic-impairment
#13
Ghassan K Abou-Alfa, Lionel D Lewis, Patricia LoRusso, Michael Maitland, Priya Chandra, Sravanthi Cheeti, Dawn Colburn, Sarah Williams, Brian Simmons, Richard A Graham
PURPOSE: Vismodegib is a Hedgehog pathway inhibitor approved for the treatment of advanced basal cell carcinoma. Currently, the pharmacokinetics (PK) and safety of vismodegib in patients with hepatic dysfunction are unknown and are the objective of this study. METHODS: Patients with advanced solid malignancies and hepatic impairment were enrolled into one of four cohorts: normal [bilirubin (bili) < upper limit of normal (ULN)], mild (ULN < bili ≤ 1...
May 18, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/28515943/evaluation-of-dosing-strategy-for-pembrolizumab-for-oncology-indications
#14
Tomoko Freshwater, Anna Kondic, Malidi Ahamadi, Claire H Li, Rik de Greef, Dinesh de Alwis, Julie A Stone
BACKGROUND: Traditionally, most monoclonal antibodies (mAbs) have been dosed based on body weight because of perceived contribution of body size in pharmacokinetic variability. The same approach was used in the initial pembrolizumab studies; however, following availability of PK data, the need for weight-based dosing for pembrolizumab was reassessed. METHODS: A previously established population PK (popPK) model as well as exposure-response results from patients with advanced melanoma or non-small cell lung cancer (NSCLC) were used to evaluate the potential application of a fixed dosing regimen with the aim of maintaining pembrolizumab exposures within the range demonstrated to provide near maximal efficacy and acceptable safety...
2017: Journal for Immunotherapy of Cancer
https://www.readbyqxmd.com/read/28513851/population-pharmacokinetics-of-brentuximab-vedotin-in-patients-with-cd30-expressing-hematologic-malignancies
#15
Hong Li, Tae H Han, Naomi N Hunder, Graham Jang, Baiteng Zhao
Brentuximab vedotin, a CD30-directed antibody-drug conjugate (ADC), is approved for treating certain patients with CD30-expressing hematologic malignancies. Its primary mechanism of action is the targeted delivery of a microtubule-disrupting agent, monomethyl auristatin E (MMAE), to CD30-expressing cells. A population pharmacokinetic (PopPK) analysis was conducted to characterize the PK of ADC and unconjugated MMAE in patients with CD30-expressing hematologic malignancies by compartmental analysis and to evaluate the effects of covariates on PK of the ADC...
May 17, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28510738/pharmacokinetic-pharmacodynamic-model-for-unfractionated-heparin-dosing-during-cardiopulmonary-bypass
#16
X Delavenne, E Ollier, S Chollet, F Sandri, J Lanoiselée, S Hodin, A Montmartin, J-F Fuzellier, P Mismetti, L Gergelé
Background: High-dose heparin is used during cardiopulmonary bypass (CPB) to prevent thrombosis in the circuits used for extracorporeal circulation. The aim of this study was, initially, to develop a population pharmacokinetic/pharmacodynamic (PK/PD) model to assess the variability of PK/PD parameters and their correlation with the results of the routine haemostatic test activated clotting time (ACT) and thereafter to develop a Bayesian estimator enabling an individualized dosing strategy...
May 1, 2017: British Journal of Anaesthesia
https://www.readbyqxmd.com/read/28509796/disposition-of-remifentanil-in-obesity-a-new-pharmacokinetic-model-incorporating-the-influence-of-body-mass
#17
Tae Kyun Kim, Shinju Obara, Talmage D Egan, Charles F Minto, Luca LaColla, David R Drover, Jaap Vuyk, Martijn Mertens
BACKGROUND: The influence of obesity on the pharmacokinetic (PK) behavior of remifentanil is incompletely understood. The aim of the current investigation was to develop a new population PK model for remifentanil that would adequately characterize the influence of body weight (among other covariates, e.g., age) on the disposition of remifentanil in the general adult population. We hypothesized that age and various indices of body mass would be important covariates in the new model. METHODS: Nine previously published data sets containing 4,455 blood concentration measurements from 229 subjects were merged...
June 2017: Anesthesiology
https://www.readbyqxmd.com/read/28508378/population-pharmacokinetic-and-pharmacodynamic-modeling-of-etelcalcetide-in-patients-with-chronic-kidney-disease-and-secondary-hyperparathyroidism-receiving-hemodialysis
#18
Ping Chen, Adimoolam Narayanan, Benjamin Wu, Per Olsson Gisleskog, John P Gibbs, Andrew T Chow, Murad Melhem
INTRODUCTION: Etelcalcetide is a novel calcimimetic that binds and activates calcium-sensing receptors (CaSRs) for the treatment of secondary hyperparathyroidism (SHPT). METHODS: To assess titrated dosing regimens, population pharmacokinetic (PK) and PK/pharmacodynamic (PKPD) modeling of etelcalcetide was performed using NONMEM 7.2. In this analysis, plasma etelcalcetide, serum parathyroid hormone (PTH) and calcium (Ca) concentration-time data were collected from five phase I, II, and III clinical trials following single or multiple intravenous doses of etelcalcetide ranging from 2...
May 15, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28508193/neutrophil-depletion-improves-diet-induced-non-alcoholic-fatty-liver-disease-in-mice
#19
Rongying Ou, Jia Liu, Mingfen Lv, Jingying Wang, Jinmeng Wang, Li Zhu, Liang Zhao, Yunsheng Xu
PURPOSE: Non-alcoholic fatty liver disease is highly associated with morbidity and mortality in population. Although studies have already demonstrated that the immune response plays a pivotal role in the development of non-alcoholic fatty liver disease, the comprehensive regulation is unclear. Therefore, present study was carried out to investigate the non-alcoholic fatty liver disease development under neutrophil depletion. METHODS: To achieve the aim of the study, C57BL/6 J mice were fed with high fat diet for 6 weeks before treated with neutrophil deplete antibody 1A8 or isotype control (200 μg/ mouse every week) for another 4 weeks...
April 6, 2017: Endocrine
https://www.readbyqxmd.com/read/28506866/non-maturational-covariates-for-dynamic-systems-pharmacology-models-in-neonates-infants-and-children-filling-the-gaps-beyond-developmental-pharmacology
#20
Karel Allegaert, Sinno H P Simons, Dick Tibboel, Elke Krekels, Catherijne Knibbe, John van den Anker
Pharmacokinetics and -dynamics show important changes throughout childhood. Studies on the different maturational processes that influence developmental pharmacology have been used to create population PK/PD models that can yield individualized pediatric drug dosages. These models were subsequently translated to semi-physiologically or physiology-based PK (PBPK) models that support predictions in pediatric patient cohorts and other special populations. Although these translational efforts are crucial, these models should be further improved towards individual patient predictions by including knowledge on non-maturational covariates...
May 12, 2017: European Journal of Pharmaceutical Sciences
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